Development and Potential Usefulness of the COVID-19 Ag Respi-Strip Diagnostic Assay in a Pandemic Context

Frontiers in Medicine

Gabriela Serrano¹  Olivier Vandenberg²  Francis Corazza³  François Bry³  Olivier Roels³  Françoise Brancart³  Brigitte Cantinieaux³  Maud Dresselhuis³  Béatrice Gulbis³  Bhavna Mahadeb³  Jacques Vanderlinden³  Fréderic Cotton³  LHUB-ULB SARS-CoV-2 Working Diagnostic Group³  Lize Cuypers⁴  Katrien Lagrou⁴  Marc Van Ranst⁴  Henri Magein⁵  Pascal Mertens⁵  Justine Bouzet⁵  Thierry Leclipteux⁵  Nathalie De Vos⁶  Pierrette Melin⁷  Nicolas Yin⁹  Sabrina Delaunoy⁹  Karolien Stoffels⁹  Sigi Van den Wijngaert⁹  Magali Wautier⁹  Delphine Martiny⁹  Vanessa Monteil^1,10  Ali Mirazimi^1,10  Davide Mileto^1,11  Christian Jassoy^1,12 

[1] 0Innovation and Business Development Unit, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium;1Division of Infection and Immunity, Faculty of Medical Sciences, University College London, London, United Kingdom;;Clinical Department of Laboratory Medicine and National Reference Center for Respiratory Pathogens, UZ Leuven, Leuven, Belgium;Coris BioConcept, Gembloux, Belgium;Department of Clinical Chemistry, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium;Department of Clinical Microbiology, Centre Hospitalier Universitaire Sart-Tilman, Université de Liège, Liège, Belgium;Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium;Department of Microbiology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium;Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden;Laboratory of Clinical Microbiology, Virology and Bioemergency, ASST Fatebene fratelli Sacco, Luigi Sacco Hospital, Milan, Italy;Medical Faculty and University Clinics, Institute for Virology, University of Leipzig, Leipzig, Germany;

关键词: COVID-19;    SARS-CoV-2;    diagnostic;    immunochromatographic test;    antigen;   

DOI  :  10.3389/fmed.2020.00225

来源: DOAJ

【 摘 要 】

Introduction: COVID-19 Ag Respi-Strip, an immunochromatographic (ICT) assay for the rapid detection of SARS-CoV-2 antigen on nasopharyngeal specimen, has been developed to identify positive COVID-19 patients allowing prompt clinical and quarantine decisions. In this original research article, we describe the conception, the analytical and clinical performances as well as the risk management of implementing the COVID-19 Ag Respi-Strip in a diagnostic decision algorithm.Materials and Methods: Development of the COVID-19 Ag Respi-Strip resulted in a ready-to-use ICT assay based on a membrane technology with colloidal gold nanoparticles using monoclonal antibodies directed against the SARS-CoV and SARS-CoV-2 highly conserved nucleoprotein antigen. Four hundred observations were recorded for the analytical performance study and thirty tests were analyzed for the cross-reactivity study. The clinical performance study was performed in a retrospective multi-centric evaluation on aliquots of 328 nasopharyngeal samples. COVID-19 Ag Respi-Strip results were compared with qRT-PCR as golden standard for COVID-19 diagnostics.Results: In the analytical performance study, the reproducibility showed a between-observer disagreement of 1.7%, a robustness of 98%, an overall satisfying user friendliness and no cross-reactivity with other virus-infected nasopharyngeal samples. In the clinical performance study performed in three different clinical laboratories during the ascendant phase of the epidemiological curve, we found an overall sensitivity and specificity of 57.6 and 99.5%, respectively with an accuracy of 82.6%. The cut-off of the ICT was found at CT <22. User-friendliness analysis and risk management assessment through Ishikawa diagram demonstrate that COVID-19 Ag Respi-Strip may be implemented in clinical laboratories according to biosafety recommendations.Conclusion: The COVID-19 Ag Respi-Strip represents a promising rapid SARS-CoV-2 antigen assay for the first-line diagnosis of COVID-19 in 15 min at the peak of the pandemic. Its role in the proposed diagnostic algorithm is complementary to the currently-used molecular techniques.

【 授权许可】

Unknown